On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.,1 addressing whether the act of importing two heart valve systems for a medical conference was within the safe harbor provision of 35 U.S.C. § 271(e)(1).2 The majority (Judges Stoll and Cunningham) affirmed that importing the allegedly infringing products fell under the safe harbor and held that the safe harbor "is available only for acts or uses that bear a reasonable relation to the development and submission of information to the" Food and Drug Administration (FDA). Judge Lourie dissented, opining that the majority improperly broadened the scope of the safe harbor. This decision is an interesting development in the application of safe harbor law to medical devices.

Background

Defendant-Appellee Meril Life Sciences ("Meril") is a medical device company that developed an artificial heart valve system as part of its Myval System.3 The Myval System initially received regulatory approval in India and Europe, and by August 2019, Meril contacted the FDA to discuss a clinical trial required for U.S. regulatory premarket approval.4 Contemporaneously, Meril engaged a consulting company to assist with the premarket approval process and attended a September 2019 conference in San Francisco to identify researchers for the clinical trial.5 Importantly, prior to the conference, Meril employees were instructed not to make any offers to sell the Myval System in the United States, and it was undisputed that Meril's employees followed such instructions.6

Leading up to the San Franciso conference, one Meril employee imported two samples of the Myval System from outside the United States to San Francisco.7 A declaration accompanied the device, stating: "This is to inform you that the demo samples carried by [the employee] is for the demonstration purpose only. It [consists] of Demo samples of Medical devices. They have no commercial value & hence it is not used for any sales purpose."8 The declaration also expressly stated that the devices were not for human use and were not approved for sale in the United States.9 It was undisputed that the Myval System samples were not shown to any individual in the United States.10 It was also undisputed that the conference was attended by researchers and clinicians.11 During the conference, Meril met with multiple doctors to identify clinicians for its clinical trial, and in late 2019 it submitted to the FDA its premarket approval application, which included a proposed clinical trial with approximately 30% of its enrolled patients being from the United States.12

Plaintiff-Appellant Edwards Lifesciences ("Edwards") sued Meril for infringement less than one month after the conference, alleging that the importation of the Myval System was an infringing act outside the Section 271(e)(1) safe harbor. The district court disagreed with Edwards and granted summary judgment of non-infringement for Meril, finding that Meril's actions were within the safe harbor.13

The Majority's Analysis

The majority affirmed that Meril's actions fell within the Section 271(e)(1) safe harbor, and Meril thus was not liable for infringement.

Section 271(e)(1) provides that it is not an act of infringement to make, use, sell, offer to sell, or import a patented invention if such act is "solely for uses reasonably related to the development and submission of information under a Federal law" that regulates medical devices and drugs.14

Starting with Supreme Court precedent, the majority explained that the safe harbor "provides a wide berth for the use of patented [inventions] in activities related to the regulatory approval process" and "extends to all uses of patented inventions that are reasonably related to the development and submission of any information" required by the FDA.15 It explained that the safe harbor "is not limited temporally" and applies to all stages of research. That is true "even if the information is never ultimately submitted to the FDA."16 The majority then explained that Federal Circuit precedent consistently has found an accused infringer's intent irrelevant because the safe harbor only requires "that the otherwise infringing act be performed 'solely for uses reasonably related' to FDA approval."17 That is, even if an accused infringer intends to use a medical device to collect data for a commercial purpose, such use is within the safe harbor so long as the use is "reasonably related" to obtaining FDA approval.18

In view of this precedent, the majority held that the word "solely" in Section 271(e)(1) modifies "for uses," meaning that the safe harbor exception is available "for acts or uses that bear a reasonable relation to the development and submission of information to the FDA."19 The majority refused to read "solely" in Section 271(e)(1) to limit the safe harbor to acts that are only or exclusively "reasonably related to the development and submission of information to the FDA," which reaffirmed that the accused infringer's intent is not dispositive on the application of the safe harbor.20 Thus, if an act is reasonably related to "the development and submission of information to the FDA," the safe harbor will apply.

Applying this standard to Meril's act of importation, the court affirmed summary judgment of non-infringement because Meril did not make any offers for sale of the Myval Systems and the act of importing two Myval Systems for the conference was related to identifying researchers for its FDA clinical trial. In other words, the act importing the Myval Systems was "reasonably related to FDA approval" and thus "firmly" within the safe harbor.21

The Dissent's Analysis

The dissent argued that the majority misread the plain language of the statute and that its decision was inconsistent with Supreme Court precedent and the statute's legislative history. Judge Lourie argued that the word "solely" in the statute must be given meaning, and that the safe harbor applies only to acts that are "solely for uses reasonably related to the development and submission of information" to the FDA.22 That is, the intent of the accused infringer is relevant to the safe harbor analysis and cannot be disregarded.23 The dissent concluded by emphasizing that the Federal Circuit could clarify the scope of the safe harbor provision by "an en banc holding" to return its scope to be consistent with the statute's legislative history.

Implications

This decision provides guidance on the scope of the safe harbor afforded to medical device and pharmaceutical companies. Developers and patent owners should evaluate manufacturing and marketing strategies and consider how those relate to activities for obtaining FDA approval.

Medical device and pharmaceutical companies should continue to monitor developments on this issue, particularly in view of the dissent's suggestion that the Appellant should seek an en banc decision from the full Federal Circuit.

Footnotes

  1. No. 2022-1877, slip op. (Fed. Cir. March 25, 2024).
  2. Id., at 1.
  3. Id., at 2.
  4. Id., at 3.
  5. Id., at 4.
  6. Id., at 4–5.
  7. Id.
  8. Id., at 5.
  9. Id.
  10. Id.
  11. Id.
  12. Id., at 5–6.

  13. Id., 6.

  14. Id., at 7 (quoting 35 U.S.C. § 271(e)(1)).
  15. Id., at 7–8 (quoting Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005)).
  16. Id., at 8 (citing Merck, 545 U.S. at 202).
  17. Id. (quoting AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997) (quoting 35 U.S.C. § 271(e)(1))).
  18. Id., at 8–10.
  19. Id., at 10 (citing Merck, 545 U.S. at 205–207).
  20. Id., at 10 (citation omitted).
  21. Id., at 11–12 (citation omitted).
  22. Id.
  23. Id.

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